Balance Exergame Training in Older Adults With a History of Falls
NCT07924579, Not applicable, Recruiting, Mahidol University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Balance Exergame Training in Older Adults With a History of Falls | ClinicalTrials.gov |
| NCT number | NCT07924579 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 42 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Mahidol University | ClinicalTrials.gov |
| Conditions | Falls (Accidents) in Old Age | ClinicalTrials.gov |
| Interventions | Nintendo Wii Fit Balance Exergame Training, Conventional Balance Training | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Fear of Falling (FES-I) | Baseline (Week 0) and post-intervention (Week 9) | The Falls Efficacy Scale-International (FES-I) is a 16-item questionnaire assessing participants' concerns about falling during daily activities. Each item is scored on a 4-point Likert scale. Total scores range from 16 to 64, with higher scores indicating greater fear of falling. | ClinicalTrials.gov |
| Primary | Montreal Cognitive Assessment (MoCA) | Baseline (Week 0) and post-intervention (Week 9) | Cognitive function is assessed using the Montreal Cognitive Assessment (MoCA), covering memory, language, attention, visuospatial function, executive function, and calculation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. | ClinicalTrials.gov |
| Primary | Forward Digit Span Test | Baseline (Week 0) and post-intervention (Week 9) | The time required to complete the forward Digit Span test is recorded in seconds (sec). This assessment evaluates the time required to perform the forward digit repetition task. | ClinicalTrials.gov |
| Primary | Percentage of Correct Responses in the Forward Digit Span Test | Baseline (Week 0) and post-intervention (Week 9) | Cognitive performance is evaluated using the forward Digit Span test. The percentage of correct responses (%) is recorded to assess performance in the forward digit repetition task. | ClinicalTrials.gov |
| Primary | Backward Digit Span Test | Baseline (Week 0) and post-intervention (Week 9) | The time required to complete the backward Digit Span test is recorded in seconds (sec). This assessment evaluates the time required to perform the backward digit repetition task. | ClinicalTrials.gov |
| Primary | Percentage of Correct Responses in the Backward Digit Span Test | Baseline (Week 0) and post-intervention (Week 9) | Cognitive performance is evaluated using the backward Digit Span test. The percentage of correct responses (%) is recorded to assess performance in the backward digit repetition task. | ClinicalTrials.gov |
| Primary | Stroop Test | Baseline (Week 0) and post-intervention (Week 9) | The time required to complete the Stroop test is recorded in seconds (sec) to evaluate the time required to perform the cognitive task involving attention and inhibitory control. | ClinicalTrials.gov |
| Primary | Percentage of Correct Responses in the Stroop Test | Baseline (Week 0) and post-intervention (Week 9) | Cognitive performance is evaluated using the Stroop test. The percentage of correct responses (%) is recorded to assess attention and inhibitory control performance. | ClinicalTrials.gov |
| Primary | Sway Area During Functional Performance Assessments | Baseline (Week 0) and post-intervention (Week 9) | Postural movement is evaluated using a marker-based three-dimensional motion capture system (Vicon). Sway area is calculated from the recorded movement trajectories during functional performance assessments and expressed in square centimeters (cm²). | ClinicalTrials.gov |
| Primary | Acceleration Time During Functional Performance | Baseline (Week 0) and post-intervention (Week 9) | Movement acceleration time is evaluated using biomechanical data obtained from a marker-based three-dimensional motion capture system during functional performance assessments. Acceleration time is recorded in seconds (sec). | ClinicalTrials.gov |
| Primary | Deceleration Time During Functional Performance | Baseline (Week 0) and post-intervention (Week 9) | Movement deceleration time is evaluated using biomechanical data obtained from a marker-based three-dimensional motion capture system during functional performance assessments. Deceleration time is recorded in seconds (sec). | ClinicalTrials.gov |
| Primary | Foot Clearance During Functional Performance | Baseline (Week 0) and post-intervention (Week 9) | Foot clearance is evaluated using marker-based three-dimensional motion capture during functional performance assessments. The vertical clearance of the foot during movement is recorded in millimeters (mm). | ClinicalTrials.gov |
| Primary | Cortical Silent Period (CSP) Duration | Baseline (Week 0) and post-intervention (Week 9) | Cortical inhibition is assessed using transcranial magnetic stimulation (TMS). Single-pulse TMS is delivered at 130% of resting motor threshold while participants maintain approximately 20% maximum voluntary contraction. CSP duration is measured as the interval between the end of the motor-evoked potential and the resumption of baseline muscle activity, expressed in seconds. | ClinicalTrials.gov |
| Primary | Change in Short-Interval Intracortical Inhibition (SICI) Threshold | Baseline (Week 0) and post-intervention (Week 9) | Intracortical inhibition is assessed using paired-pulse transcranial magnetic stimulation (TMS). The change (Δ) in the threshold of short-interval intracortical inhibition is evaluated and expressed as a percentage (%). This parameter represents the SICI threshold change specified as a primary outcome in the study protocol. | ClinicalTrials.gov |
| Primary | Central Motor Conduction Time (CMCT) | Baseline (Week 0) and post-intervention (Week 9) | Central motor conduction time is assessed using peripheral nerve stimulation and measurement of M-waves and F-waves. The measurements are used to evaluate motor pathway conduction. CMCT is recorded in seconds (sec). | ClinicalTrials.gov |
| Secondary | Cold Detection Threshold (CDT) | Baseline (Week 0) and post-intervention (Week 9) | Cold detection threshold is assessed using quantitative sensory testing (QST) with an air-cooled probe applied to the dorsum of the right foot. The baseline temperature is set at 32°C, and the cold detection threshold is determined using the standardized 4-2-1 stepping algorithm. Results are expressed in degrees Celsius (°C). | ClinicalTrials.gov |
| Secondary | Vibration Detection Threshold (VDT) | Baseline (Week 0) and post-intervention (Week 9) | Vibration detection threshold is assessed using quantitative sensory testing (QST). A vibration stimulus probe is applied to the right metatarsal bone, and the detection threshold is determined using the standardized 4-2-1 stepping algorithm. Results are expressed in micrometers (µm). | ClinicalTrials.gov |
| Secondary | Lower-Limb Angular Velocity During Walking | Baseline (Week 0) and post-intervention (Week 9) | Lower-limb angular velocity is evaluated during walking using a marker-based three-dimensional motion capture system. Angular velocity is calculated from the recorded lower-limb movement data and expressed in degrees per second (°/sec). | ClinicalTrials.gov |
| Secondary | Resting Motor Threshold (RMT) | Baseline (Week 0) and post-intervention (Week 9) | Resting motor threshold is assessed using transcranial magnetic stimulation (TMS). It is defined as the minimum stimulation intensity required to elicit a motor-evoked potential greater than 50 µV in at least 5 of 10 consecutive trials while the target muscle is relaxed. Results are expressed as a percentage (%) of maximum stimulator output. | ClinicalTrials.gov |
| Secondary | Active Motor Threshold (AMT) | Baseline (Week 0) and post-intervention (Week 9) | Active motor threshold is assessed using transcranial magnetic stimulation (TMS) while participants maintain a 10-20% maximum voluntary contraction. It is defined as the minimum stimulation intensity required to elicit a motor-evoked potential greater than 200 µV in at least 5 of 10 consecutive trials. Results are expressed as a percentage (%) of maximum stimulator output. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)